Ketotifen Impurity 16 CAS CATO-C4X-204616
| CAS No. | CATO-C4X-204616 |
| Molecular Formula | C19H20NO3S |
| Molecular Weight | 342.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Ketotifen Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
As a process- or degradation-related impurity, Ketotifen Impurity 16 (CAS CATO-C4X-204616, C19H20NO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Ketotifen Impurity 16 (C19H20NO3S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
Physical & Chemical Properties
| Molecular Formula | C19H20NO3S |
| Molecular Weight | 342.43 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Ketotifen Standards
- Ketotifen Impurity 14 (CAS CATO-C4X-204614)
- Ketotifen EP Impurity B (Enantiomer Mixture) (CAS 59743-88-3)
- Ketotifen Impurity 25 (CAS CATO-C4X-204625)
- Ketotifen Impurity 27 (CAS CATO-C4X-204627)
- Ketotifen Impurity 26 (CAS CATO-C4X-204626)
- Ketotifen EP Impurity C (CAS 126939-27-3)
- Ketotifen Impurity 35 (CAS CATO-C4X-204635)
- Ketotifen EP Impurity D (CAS 88456-70-6)
Recommended Standards
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- Labetalol Impurity 82 (CAS CATO-C4X-246682)
- Dabrafenib Impurity 23 (CAS CATO-C4X-303323)
- Alanyl Glutamine Impurity 19 (CAS 888939-48-8)
- Crisaborole Impurity 61 (CAS CATO-C4X-202161)
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- 2-Amino-5-(2-methoxyphenyl)-1,3,4-thiadiazole (CAS 28004-56-0)
- 5-Acetyl-2-methoxybenzoic acid (CAS 68535-61-5)
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- 1-Methyl-3-(2,3,4-trifluorophenyl)-1h-pyrazol-5-amine (CAS 1502556-35-5)
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